Phase II Feasibility Study of Weekly Paclitaxel Followed by Weekly Doxorubicin Plus Daily Oral Cyclophosphamide for Locally Advanced HER2-Negative Breast Cancer

Instituto do Cancer do Estado de São Paulo1 site in 1 country12 target enrollmentAugust 2010

ConditionsLocally Advanced HER2-negative Breast Cancer

InterventionsPaclitaxel/doxorubicin/cyclophosphamide

DrugsPaclitaxel/doxorubicin/cyclophosphamide

Overview

Phase: Phase 2
Intervention: Paclitaxel/doxorubicin/cyclophosphamide
Conditions: Locally Advanced HER2-negative Breast Cancer
Sponsor: Instituto do Cancer do Estado de São Paulo
Enrollment: 12
Locations: 1
Primary Endpoint: Incidence of febrile neutropenia
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine whether weekly paclitaxel followed by weekly doxorubicin plus daily oral cyclophosphamide without granulocyte colony-stimulating factor (G-CSF) is feasible in the treatment of locally advanced HER2-negative breast cancer.

Registry

clinicaltrials.gov

Start Date

August 2010

End Date

August 2012

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Instituto do Cancer do Estado de São Paulo

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Locally advanced breast cancer diagnosed by guided core biopsy
•T \> 2 cm (any N), or any T and node positive (needle biopsy is required)
•Non-metastatic disease assessed by computed tomography and bone scintigraphy
•Histological grade 2 and Ki67 \> 15% or
•Histological grade 3 or
•Any triple negative (TN) or
•Inflammatory breast cancer (IBC)
•Normal left ventricular ejection fraction (LVEF)
•HER2-negative disease

Exclusion Criteria

•Another malignancy within the last 5 years (except curatively treated skin carcinoma, in situ cervix carcinoma, in situ ductal carcinoma of the breast, or in situ lobular carcinoma of the breast)
•Clinically significant comorbidities as cardiovascular diseases, chronic obstructive pulmonary disease (COPD), renal or liver failure, psychiatric disorders
•LVEF value below institutional limits of normal
•Predominant lobular carcinoma histology
•Grade 1 tumors
•Detected or suspicious distant metastasis
•Neutrophils less than 1,500/µL, platelets less than 100,000/µL, hemoglobin less than 10 g/dL, AST more than 2.5x upper limit of normal (ULN), total bilirubin more than ULN, alkaline phosphatase more than 1.5x ULN
•HER2-positive breast cancer